Low profile catheter valve and inflation adaptor

ABSTRACT

Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port. Also disclosed herein is an inflation adaptor for moving the sealer portion within the catheter to establish or close the fluid pathway between the inflation port and the inflatable balloon.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application is a continuation of application Ser. No.09/410,456, filed Oct. 1, 1999, now U.S. Pat. No. 6,325,777, which is adivisional of application Ser. No. 08/975,723, filed Nov. 20, 1997, nowU.S. Pat. No. 6,050,972, which is a continuation-in-part of applicationSer. No. 08/812,139, filed Mar. 6, 1997, abandoned, which iscontinuation-in-part of application Ser. No. 08/650,464 filed on May 20,1996, abandoned, the entirety of each of which is hereby incorporated byreference.

BACKGROUND OF THE INVENTION

[0002] The present invention generally relates to catheters, and inparticular, to a detachable inflation adaptor for a catheter having alow profile valve which may be opened to permit inflation or deflationof a catheter balloon, such as an occlusion balloon, and which may beclosed when it is desirable to maintain the catheter balloon in aninflated state.

[0003] Guidewires are conventionally used to guide the insertion ofvarious medical instruments, such as catheters, to a desired treatmentlocation within a patient's vasculature. In a typical procedure, theclinician forms an access point for the guidewire by creating an openingin a peripheral blood vessel, such as the femoral artery. The highlyflexible guidewire is then introduced through the opening into theperipheral blood vessel, and is then advanced by the clinician throughthe patient's blood vessels until the guidewire extends across thevessel segment to be treated. Various treatment catheters, such as aballoon dilatation catheter for a percutaneous transluminal coronaryangioplasty, may then be inserted over the guidewire and similarlyadvanced through vasculature until they reach the treatment site.

[0004] In certain treatment procedures, it is desirable to successivelyintroduce and then remove a number of different treatment catheters overa guidewire that has been placed in a particular location. In otherwords, one treatment catheter is “exchanged” for another over a singleguidewire. Such an exchange typically involves withdrawing the treatmentcatheter over the guidewire until the treatment catheter is fullyremoved from the patient and the portion of the guidewire which extendsfrom the patient. The guidewire is then available to act as a guide fora different treatment catheter.

[0005] In emboli containment devices, which typically utilize twoocclusion balloons to form a chamber, it may be desirable to exchangetherapeutic catheters without deflating the occlusion balloons. Further,it is sometimes advantageous to anchor the guidewire during theexchange. As can be readily appreciated, the withdrawal of treatmentcatheters over a placed guidewire may result in the guidewire beingdisplaced from its position. To overcome this difficulty, the prior arthas developed “anchorable” guidewires, which generally feature somestructure on their distal ends to releasably secure the guidewire at aparticular location in the patient for the duration of the medicalprocedure. One such anchorable guidewire is disclosed in U.S. Pat. No.5,167,239 to Cohen et al., which discloses a hollow guidewire with aninflation lumen and an expandable balloon on its end. The Cohenguidewire is positioned in the same manner as a conventional wireguidewire, but once placed, its expandable balloon is inflated tocontact the surrounding vasculature, thereby preventing the guidewirefrom being displaced.

[0006] Because a permanent inflation manifold, of the type used withconventional catheters having an inflatable balloon, would prevent othercatheters from being inserted over the Cohen guidewire, the Cohen devicealso includes a removable inflation manifold, and a check valve tomaintain the balloon in the inflated state when the manifold is removed.The check valve apparatus used by the Cohen device is relatively bulky,and is described as having an outer diameter in its preferred embodimentof 0.0355 inches. Consequently, any treatment catheter intended to beinserted over the Cohen device must have an interior guidewire lumenlarger than the outer diameter of the Cohen valve, which for thepreferred embodiment, requires an interior lumen with a diameter of morethan 0.0355 inches.

[0007] As is readily appreciated by those of skill in the art,increasing the interior lumen size of a treatment catheter results in anincrease in the outer diameter of the treatment catheter. For treatmentprocedures which take place in vasculature having a large blood vesseldiameter, such as iliac arteries, a treatment catheter guidewire lumenof a size necessary to accommodate devices such as those described byCohen would have little or no affect on the ability of the catheter tofit within the blood vessel. However, many blood vessels where it isdesirable to apply catheter treatment are quite narrow. For example, theleft coronary arteries are blood vessels having diameters ranging from 2to 4 mm, and are susceptible to plaque. It would be desirable to use acatheter exchange treatment procedure, such as angioplasty, to treatsuch lesions, but the narrow diameter of the coronary vessels makes useof anchorable guidewires having large valve diameters impractical.

[0008] Consequently, there exists a need for a very low profile cathetervalve which can be used with a hollow guidewire. Furthermore, thereexists a need for a detachable inflation adaptor which can be used withsuch low profile valves to open and close them, and to apply inflationor deflation forces to the catheter balloons.

SUMMARY OF THE INVENTION

[0009] The present invention provides a catheter valve which is capableof very low profiles, and is especially advantageous for use withanchorable guidewires, as well as therapeutic or occlusion devices. Byincorporating this into such devices, it is possible to manufactureanchorable guidewires and occlusion device catheters with outerdiameters of 0.014 inches or smaller. Advantageously, by utilizing thisvalve in these catheters, clinicians will be able to use anchorableguidewires, therapeutic or occlusion device catheters in much narrowerblood vessels than in the past.

[0010] The present invention also provides for a detachable inflationadaptor which can be used with catheters having these low profilevalves. The adaptor can be attached tot he catheter to open the valve,and then apply inflation fluid to inflate the catheter balloon.Following this, the valve may then be closed and the adaptor removed,with the balloon remaining in its inflated state and the catheter nowable to function as an anchored guidewire. When it is desired to deflatethe balloon, the adaptor may be once again attached to the catheter, thevalve opened, and the inflation fluid removed to deflate the balloon.

[0011] In one aspect of the present invention, there is provided a valvewhich comprises a flexible elongate tubular body having a proximal endand a distal end. The tubular body has a central lumen extending betweenthe proximal and distal ends. The central lumen has an opening at theproximal end.

[0012] An expandable member, such as an inflatable balloon, ispositioned on the distal end of the tubular body. The expandable memberis in fluid communication with the central lumen. An access opening isprovided on the tubular body. The access opening is in fluidcommunication with the central lumen to permit the expandable member tobe actuated by pressurizing the access opening. The access opening maybe the central lumen opening or a side-access port positioned on thetubular body at a point proximal to the distal end of the tubular body.

[0013] A sealing member is provided having a sealer portion which sealsagainst a surface of the tubular body. The sealing portion of thesealing member is movable relative to the surface of the tubular bodybetween two positions. In the first position, the sealer portion ispositioned in contact with the tubular body surface at a location whichblocks the flow of fluid to or from the expandable member through theaccess opening to maintain actuation of the expandable member. In thesecond position, the sealer portion is positioned at a location whichpermits the flow of fluid to or from the expandable member through theaccess opening to permit actuation or deactuation of the expandablemember.

[0014] In one preferred embodiment, the sealing member has a portionwhich extends from the proximal end of the tubular body, and theapplication of a longitudinal force on the extending portion results inmovement of the sealer portion in the direction of the applied force. Inother embodiments, rotational forces may be used to move the sealingmember.

[0015] There is also preferably provided a force-increasing structurewhich increases the longitudinal force which must be applied to theextending portion to move the sealer portion.

[0016] The sealer portion is preferably formed of a polymeric material,such as PEBAX (TM), silicone, C-FLEX(TM) or gels. The sealer portion iscapable of withstanding pressures up to ten atmospheres and preventsubstantially all fluid from passing to or from the expandable memberthrough the access opening when the sealer portion is positioned distalto the access opening. The sealer portion is also capable of undergoing10 valve-opening and closing cycles, and, at a pressure of tenatmospheres, still prevent substantially all fluid from passing to orfrom the balloon when the sealer portion is positioned distal to theaccess opening. At least a portion of the sealing member is selectedfrom the group of metals consisting of nitinol, stainless steel,Elgiloyθ or combinations thereof.

[0017] Advantageously, the outer diameter of the tubular body isgenerally larger than the outer diameter of any portion of the sealingmember or sealer portion. In some embodiments, the outer diameter of thetubular body is no greater than 0.038 inches, preferably no greater than0.020 inches, and more preferably no greater than 0.014 inches. Otherembodiments may have larger outer diameters for the tubular body. Thetubular body may also have positive stops to prevent withdrawal of thesealing member from the opening.

[0018] There is also preferably provided in combination with this valvean inflation adaptor capable of receiving the valve. The inflationadaptor provides a fluid-tight chamber for introduction of a pressurizedfluid to expand the expandable member.

[0019] In another aspect of the present invention, there is provided anapparatus, comprising a hollow metallic guidewire having a central lumenand a side-access port in fluid communication with the lumen. Aninflatable balloon is mounted on the guidewire, the inflatable balloonbeing in fluid communication with the central lumen, such that fluidintroduced through the side-access port can be used to inflate theballoon.

[0020] A valve is mounted to slide along a surface of the guidewire, thevalve movable between first and second positions, one of the positionssealing the central lumen such that substantially no fluid may pass toor from the inflatable balloon by way of the side-access port.

[0021] Preferably, the hollow guidewire has an outer circumferencedefining a first value, and the movable valve has a circumference whichis less than the first value. It is also preferred that the hollowguidewire have an outer circumference of 0.12 inches or less, morepreferably 0.08 inches or less, and optimally 0.044 inches or less, andthat the movable valve have a diameter not substantially larger thanthat of the hollow guidewire, and the valve seals against an interiorsurface of the hollow guidewire.

[0022] In another aspect of the present invention there is provided alow profile catheter valve which comprises a sealing member capable ofbeing movably inserted through a proximal opening on a catheter into aninflation lumen of the catheter. The catheter has a side-accessinflation port and an inflatable balloon in fluid communication with theside-access inflation port. A sealer portion is on the sealing member,the sealer portion being capable of forming a fluid tight seal with theentire circumference of a section of the lumen, such that substantiallyall fluid may not pass the sealer portion at normal balloon inflationpressures.

[0023] When the sealer portion is positioned within the lumen proximallyof the side-access inflation port, an unrestricted fluid pathway isestablished between the side-access inflation port and the balloon. Whenthe sealer portion is positioned within the lumen distally of theside-access inflation port, substantially all fluid may not pass to orfrom the balloon through the side-access inflation port at normalballoon inflation pressures.

[0024] In another aspect of the present invention, there is provided amethod of inflating a catheter balloon. The first step of the methodinvolves providing a tube having a proximal end and a distal end. Theproximal end of the tube has an inflation opening to an inflation lumenand the distal end has an inflatable balloon in fluid communication withthe inflation lumen. A pressurized inflation fluid is then introducedthrough the inflation opening to inflate the balloon. The inflationopening may then be sealed by moving a sealing member within theinflation lumen without reducing the pressure of the pressurized fluid,wherein the step of sealing is performed without substantial deflationof the inflated balloon. Finally, the pressure of the pressurized fluidmay be reduced after completing the sealing step.

[0025] In another aspect of the present invention, there is provided alow profile catheter valve for use with an inflation adaptor. The valvecomprises a sealing member capable of being movably inserted through aproximal opening on a catheter into an inflation lumen of the catheter.The catheter has an inflation opening and an inflatable balloon in fluidcommunication with the inflation opening. Indicia are present on thecatheter and/or sealing member, the position of the indicia being suchthat the inflation opening is aligned with a fluid tight inflationchamber of the inflation adaptor when the catheter and sealing memberare secured in the inflation adaptor.

[0026] A sealer portion is mounted on the sealing member. The sealerportion is capable of forming a fluid tight seal with the entirecircumference of a section of the lumen, such that substantially allfluid may not pass the sealer portion at normal balloon inflationpressures. When the sealer portion is positioned proximally of theinflation opening, an unrestricted fluid pathway is established betweenthe inflation opening and the balloon. When the sealer portion ispositioned distally of the inflation opening, substantially all fluidmay not pass to or from the balloon through the side-access inflationport.

[0027] In another aspect of the present invention, there is provided aninflation adaptor for introducing inflation fluid into an inflation portof an elongate tube. The inflation adaptor comprises a housing havingfirst and second portions which interact to releasably retain a sectionof the tube therein. The housing has a chamber which receives theinflation port. An inflation inlet configured to be connected to asource of inflation fluid that supplies the fluid under pressure ispositioned on the housing. The housing also has a seal which releasablyseals the portions of the housing together, and provides a fluid pathwaybetween the inflation inlet and the inflation port, so that fluid may besupplied to the inflation port under pressure. The seal is created byalignment of a first and second gasket on the housing portions. Anactuator, mounted on the housing, drives a member within the tube tocontrol fluid flow through the catheter inflation port. The actuator maycontrol sliding panels which drive the tube members in some embodiments.Preferably, there are indicia on the elongate tube and housing whichfacilitate alignment of the catheter inflation port and the housingchamber.

[0028] In another aspect of the present invention, there is provided aninflation adaptor for introducing inflation fluid into an inflation portof an elongate tube. The inflation adaptor comprises a housing havingfirst and second portions. The portions of the housing are relativelymovably mounted to receive a section of the elongate tube which includesthe inflation port. The housing also has an inflation chamber and aninflation inlet for introducing inflation fluid under pressure into theinflation chamber. The inflation chamber releasably seals the inflationport to the inflation inlet to form a fluid passage therebetween.

[0029] In another aspect of the present invention, there is provided aninflation adaptor for introducing inflation fluid into an inflation portof an elongate tube. The inflation adaptor comprises a housing havingfirst and second portions. The two portions form a mouth for receiving asection of the tube which includes the inflation port. The mouth formsan opening having a height at least as great as the outer diameter ofthe tube such that the section of tube is insertable into the mouth fromits side in a direction transverse to the longitudinal axis of the tube.The housing also has an inflation chamber and an inflation inlet forintroducing inflation fluid under pressure into the inflation chamber.The inflation chamber releasably seals the inflation port to theinflation inlet to form a fluid passage there between.

[0030] In another aspect of the present invention, there is provided aninflation adaptor for introducing inflation fluid into an inflation portof an elongate tube. The tube has an inflatable member mounted thereonand an inflation lumen between the inflation port and the inflatablemember. The adaptor has a housing configured to seal over the tubularbody to create a fluid tight seal. An inflation inlet is on the housing,for establishing a fluid pathway between the inflation inlet and theinflation port to permit the inflatable member to be inflated. Thehousing is detachable from the tube without deflating the inflatedinflatable member.

[0031] In another aspect of the present invention, there is provided aninflation adaptor for introducing inflation fluid into an inflation portof an elongate tube having an inflatable member mounted thereon and aninflation lumen between the inflation port and the inflatable member.The adaptor comprises a housing with an upper portion and a lowerportion. The housing is configured to seal over the tube to create afluid tight inflation chamber. The housing also has an inflation inletand establishes a fluid pathway between the inflation inlet and theinflation port to permit the inflatable member to be inflated. Thehousing is detachable from the tube without deflating the inflatedinflatable member.

[0032] A latch with a camming surface is on the housing, and is adaptedto secure the housing upper portion to the housing lower portion. Acammed surface is on the housing upper, and is adapted to receive thecamming surface. With this structure, when a user exerts a force on thelatch to secure the upper portion to the lower portion, the cammingsurface cooperates with the cammed surface to provide a closing force onthe upper and lower portions which is greater than the force exerted bythe user.

[0033] In one preferred embodiment, the upper portion has a firstgasket, and the lower portion has a second gasket, and the fluid tightinflation chamber is established when the gaskets are brought togetherand secured by the latch. Preferably, the upper portion has a movablepanel with the movement being controlled by an actuator on the housingthat is accessible to a clinician when the adaptor is in use. There isalso a lower movable panel on the lower housing portion, which iscapable of being moved in conjunction with the upper portion movablepanel when the fluid tight inflation chamber is established.

[0034] In another prefered embodiment, a spring biased rod is connectedto the lower portion movable panel, the spring biased rod defining thedistance in at least one dimension that the upper portion movable paneland lower portion movable panel may travel when the fluid tightinflation chamber is established. The movable panel are preferablymovable for a distance of greater than 1 mm, and more preferably for adistance of greater than 5 mm.

[0035] In another aspect of the present invention, there is provided alow profile catheter valve sealing member. The sealing member has anextension wire with a proximal end and a distal end. The extension wiretapers at the distal end. A connecting hypotube is attached to theextension wire proximal end. The connecting tube has a tapering distalend. A plug mandrel wire is attached to the hypotube distal end. Asealer portion is on the plug mandrel wire, the sealer portion beingcapable of forming a fluid tight seal with the entire circumference of asection of a catheter lumen.

[0036] In another aspect of the present invention, there is provided alow profile catheter valve sealing member for a catheter having a lumenwith a first diameter. The sealing member has a first region having adiameter greater than the first diameter, and a tapering portionresulting in a second region with a diameter less than the firstdiameter. The second region is slidably inserted in the catheter lumen.A plug mandrel wire is connected to the second region at the distal endof the second region, the plug mandrel wire having a diameter smallerthan the second region diameter. A sealer portion is on the plug mandrelwire, the sealer portion being capable of forming a fluid tight sealwith the entire circumference of a section of a catheter lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

[0037]FIG. 1 is a side view of a catheter incorporating the low profilevalve of the present invention.

[0038]FIG. 2 is an enlarged view of the proximal portion of the catheterof FIG. 1, showing an exterior view of the catheter segment featuringthe low profile valve of the present invention.

[0039]FIG. 3A is a longitudinal cross-sectional view of the cathetersegment of FIG. 2, showing the low profile valve in the open position.

[0040]FIG. 3B is a longitudinal cross-sectional view of the cathetersegment of FIG. 2, showing the low profile valve in the closed position.

[0041]FIG. 4 is a longitudinal cross-sectional view of an alternativeembodiment, showing the low profile valve in the closed position.

[0042]FIG. 5 is a longitudinal cross-sectional view of the embodiment ofFIG. 4, showing the low profile valve in the open position.

[0043]FIG. 6 is a longitudinal cross-sectional view of an alternativeembodiment of the low profile valve, depicting the valve in the openposition

[0044]FIG. 7 is a longitudinal cross-sectional view of the embodiment ofFIG. 6, depicting the valve in the closed position.

[0045]FIG. 8 is a perspective view of an inflation adaptor used tomanipulate the low profile valve of the present invention.

[0046]FIG. 9A is a perspective view of the interior of the inflationadaptor of FIG. 8.

[0047]FIG. 9B is a perspective view of a catheter with a sealing memberand alignment indicia being positioned in the inflation adaptor of FIG.9A.

[0048]FIG. 10 is an end view of an alternative embodiment of theinflation adaptor.

[0049]FIG. 11 is a cross-sectional view of the inflation adaptor of FIG.10 along lines 10-10.

[0050]FIGS. 12 and 13 are exploded views of alternative embodiments ofthe low profile valve of the present invention.

[0051]FIG. 14 is an alternative embodiment of the valve of the presentinvention featuring a built in spring bias.

[0052]FIGS. 15A and 15B are longitudinal cross-sectional views of thecatheter proximal end of FIG. 14, showing the valve in the closed andopen position, respectively.

[0053]FIG. 16 is a perspective view of an alternative embodiment of aninflation adaptor used to manipulate the low profile valve of thepresent invention.

[0054]FIG. 17 is a perspective view of the interior of the inflationadaptor of FIG. 16.

[0055]FIGS. 18A and 18B are top views of the inflation adaptor of FIGS.16 and 17, illustrating the latch locking mechanism.

[0056] FIGS. 19A-19C are schematic cross-sectional views of the adaptorof FIG. 16, which illustrate the cam locking door mechanism whichprovides mechanical advantage to the adaptor locking latch.

[0057] FIGS. 20A-C are close-up views of an embodiment of the adaptorhaving a sliding top panel biased by a spring mechanism.

[0058]FIGS. 21 and 22 are cross-sectional views of a proximal section ofa catheter having an alternative embodiment of the valve of the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0059] Referring to FIG. 1, there is depicted a catheter 10incorporating the low profile valve of the present invention. Althoughillustrated in the context of a simple occlusion balloon catheter,having a single inflation lumen and a single inflatable balloon, it isto be understood that the low profile valve of the present invention canbe readily adapted to a wide variety of balloon catheters, includingthose having additional functionalities, structures, or intended uses.For example, the low profile valve could be easily adapted to cathetershaving expandable members other than occlusion balloons, such astherapeutic dilatation balloons. Furthermore, the low profile valve ofthe present invention may also be incorporated into catheters having twoor more lumens. The manner of adapting the low profile valve of thepresent invention to catheters having these various functionalities,structures, or intended uses will become readily apparent to those ofskill in the art in view of the description which follows.

[0060] Catheter 10 generally comprises an elongate flexible tubular body18 extending between a proximal control end 12 and a distal functionalend 14. Tubular body 18 has a central lumen 40 which extends betweenends 12 and 14. Lumen 40 has an opening 23 at proximal end 12, and issealed fluid tight at distal end 14. The length of tubular body 18 maybe varied considerably depending upon the desired application. Forexample, where catheter 10 is to be used as a guidewire for othercatheters in a conventional percutaneous transluminal coronaryangioplasty procedure involving femoral artery access, lengths oftubular body 18 in the range of from about 120 to about 300 centimetersare preferred, with a length of about 180 centimeters often being used.Alternately, for a different treatment procedure, not requiring as longa length of tubular body 18, shorter lengths of tubular body 18 may beprovided.

[0061] Typically, tubular body 18 will have a generally circularcross-sectional configuration with an outer diameter within the range offrom about 0.010 inches to 0.044 inches. Optimally, in most applicationswhere catheter 10 is to be used as a guidewire for other catheters, theouter diameter of tubular body 18 ranges from 0.010 inches to 0.038inches, and preferably is 0.020 inches in diameter or smaller, morepreferably 0.014 inches in outer diameter or smaller. The diameter oflumen 40 will be dictated, in part, by the outside diameter of tubularbody 18. For example, where tubular body 18 has an outer diameter of0.014 inches, central lumen 40 may have an inner diameter of from about0.008 inches to about 0.010 inches. The diameter of lumen 40 should belarge enough to incorporate the low profile valve described below, andlarge enough to permit sufficient fluid passage for balloon inflation.

[0062] Noncircular cross-sectional configurations of lumen 40 can alsobe adapted for use with the low profile valve of the present invention.For example, triangular rectangular, oval, and other noncircularcross-sectional configurations are also easily incorporated for use withpresent invention, as will be appreciated by those of skill in the art.The manner of adapting the valve of the present invention will becomereadily apparent in view of the description which follows.

[0063] In the preferred embodiment, the tubular body 18 functions as aguidewire, and thus, tubular body 18 must have sufficient structuralintegrity, or “pushability,” to permit catheter 10 to be advancedthrough vasculature to distal arterial locations without buckling orundesirable bending of tubular body 18. It is also desirable for tubularbody 18 to have the ability to transmit torque, such as in thoseembodiments where it may be desirable to rotate tubular body 18 afterinsertion into a patient. A variety of biocompatible materials, known bythose of skill in the art to possess these properties and to be suitablefor catheter manufacture, may be used to fashion tubular body 18. Forexample, tubular body 18 may be made of stainless steel, or may be madeof polymeric materials such as nylon, polyamide, polyimide,polyethylenes, or combinations thereof. In one preferred embodiment, thedesired properties of structural integrity and torque transmission areachieved by forming tubular body 18 out of an alloy of titanium andnickel, commonly referred to as nitinol. In a more preferred embodiment,the nitinol alloy used to form tubular body 18 is comprised of about50.8% nickel and the balance titanium, which is sold under the tradename TINEL (TM) by Memry Corp. It has been found that a catheter tubularbody having this composition of nickel and titanium exhibits greatflexibility and improved kink resistance in comparison to othermaterials. One preferred embodiment of tubular body 18 is disclosed inour copending application entitled HOLLOW MEDICAL WIRES AND METHODS OFCONSTRUCTING SAME, application Ser. No. 08/812,876, filed on Mar. 6,1997, now U.S. Pat. No. 6,068,623, the entirety of which is incorporatedherein by reference.

[0064] The distal end 14 of catheter 10 is provided with an atraumaticdistal tip 16, and an inflatable balloon 20, as illustrated in FIG. 1.Inflatable balloon 20 may be made from any of a variety of materialsknown by those of skill in the art to be suitable for balloonmanufacture. For example, inflatable balloon 20 may be formed ofmaterials having a compliant expansion profile, such as polyethylene orlatex. In one preferred embodiment, where inflatable balloon 20 is to beused as an occlusion balloon, it is preferably formed of a blockcopolymer of styrene-ethylene-butylene-styrene (SEBS), sold under thetrade name C-FLEX (TM). One preferred embodiment of a C-FLEX occlusionballoon is disclosed in our copending application entitled PRE-STRETCHEDCATHETER BALLOON, application Ser. No. 08/812,140, filed on Mar. 6,1997, now U.S. Pat. No. 5,868,705, the entirety of which is incorporatedherein by reference. Alternately, in those embodiments where inflatableballoon 20 is to serve as a dilatation balloon, it may be formed ofmaterials having a noncompliant expansion profile, such as polyethyleneterephthalate. Inflatable balloon 20 may be attached to tubular body 18in any manner known to those of skill in the art, such as heat bondingor through use of adhesives.

[0065] As shown in FIG. 1, catheter 10 is provided with a side-accessinflation port or opening 22 formed in tubular body 18 at a pointseveral centimeters distal from opening 23. Inflation port 22 is influid communication with central lumen 40 extending through tubular body18. A fill hole (not shown) is formed in tubular body 18 within theregion enclosed by inflatable balloon 20, such that fluid passingthrough inflation port 22 and into lumen 40 may inflate balloon 20.Conversely, an inflated balloon 20 can be deflated by withdrawal offluid from balloon 20, through lumen 40, and out of side-accessinflation port 22.

[0066] The low profile valve of the present invention may be used withcatheters such as that described above, all well as with differentcatheters having different structures. In one preferred embodiment, thelow profile valve comprises a sealing member which is movably positionedwithin the inner lumen of a catheter. The catheter has an inflationport, which, in some embodiments, is also an opening to the inner lumenat the proximal end of the catheter. An inflatable balloon is positionedon the distal end of the catheter, which is in fluid communication withthe lumen and inflation port. The sealing member is inserted through theproximal opening into the lumen, with a portion of the sealing memberextending outwardly from the proximal end of the catheter. The portionof the sealing member inserted into the lumen has a sealer portion whichforms a fluid tight seal with the inner lumen to prevent fluid frompassing past the sealer portion.

[0067] By application of a pushing or pulling force on the extendingsealing member portion, the sealing member may be partially advancedwithin or withdrawn from the lumen, thereby moving the sealer portionwithin the lumen. In this manner, the sealer portion may be positionedwithin the lumen either proximally or distally of the inflation port.When the sealer portion is positioned proximally of the port, the valveis in the “open” position. When the valve is open, an unrestricted fluidpathway is established between the inflation port and the balloon, suchthat an external pressurized fluid source may be connected to theinflation port to inflate the balloon, or if the balloon is alreadyinflated, the balloon may be deflated by application of a vacuum to theinflation port to withdraw fluid from the balloon. When the sealerportion is positioned distally of the inflation port, the valve is inthe closed position, as the fluid tight seal between the lumen and thesealer portion prevents fluid from passing either to or from the balloonthrough the inflation port. Furthermore, when the valve is closed afterballoon inflation, the fluid tight seal created by the sealer portionmaintains the balloon in the inflated state in the absence of anexternal fluid source, by preventing the pressurized fluid within theballoon from escaping.

[0068] Referring to FIGS. 2, 3A and 3B, there is depicted one embodimentof the low profile valve of the present invention, as used with thecatheter of FIG. 1. Catheter 10, as described above, has a side-accessinflation port 22 which is in fluid communication with central lumen 40,and through which fluid may be introduced to inflate balloon 20. Centrallumen 40 has an opening 23 at proximal end 12. A sealing member 30 isinserted into lumen 40 through opening 23. Sealing member 30 may bepartially advanced within or withdrawn from lumen 40 by the applicationof a longitudinal force on sealing member 30 directed toward or awayfrom proximal end 12, respectively.

[0069] Sealing member 30 comprises a main shaft 33, a tapering region31, and a wire 32. Sealing member 30 may be formed as solid piece out ofsuitable metals, such as stainless steel, nitinol and the like. Forexample, sealing member 30 may be formed as a solid cylindrical piece,and then be coined down at points along its length to form taperingregion 31 and wire 32. Alternately, one or more of the main shaft 33,tapering region 31, or wire 32 may be formed separately, and thenattached to the other piece(s) by conventional means, such as soldering,to form sealing member 30. Polymeric materials, such as DELRON (TM),nylon, and the like, may also be used to form sealing member 30, eitheras a solid piece, or as separate pieces which are later joined to formthe sealing member.

[0070] Although not required, in one preferred embodiment, main shaft 33has an outer diameter no larger than the outer diameter of the cathetertubular body 18. Thus, if the outer diameter of tubular body 18 is 0.014inches, the diameter of main shaft 33, and thus the largest diameter ofsealing member 30, is no larger than 0.014 inches. Furthermore, it isalso preferred that main shaft 33 extend proximally from opening 23 by adistance of at least several centimeters to facilitate the applicationof longitudinal forces on main shaft 33 to manipulate the position ofwire 32 in lumen 40. Moreover, after catheter 10 has been fully insertedinto a patient, an extending main shaft 33 advantageously functions muchlike a conventional guidewire extension, providing a starting point forthe clinician to insert other catheters over main shaft 33 and catheter10.

[0071] The combined length of catheter 10 and extending main shaft 33may be varied considerably at the point of manufacture, and may beadapted to the requirements of the other catheters which are to be usedwith catheter 10 and main shaft 33. For example, where catheter 10 is tobe used as a guidewire for other catheters in an “over-the-wire”embodiment, it is preferred that the total length of catheter 10 withextending main shaft 33 be about 300 centimeters. Alternately, whencatheter 10 is to be used as a guidewire for other catheters in a singleoperator embodiment, or “RAPID-EXCHANGE” embodiment, it is preferredthat the total length of catheter 10 with extending main shaft 33 beabout 180 centimeters. As can be readily appreciated, the individuallengths of catheter 10 and extending main shaft 33 can be variedconsiderably and yet still achieve the overall desired combined length.For example, a catheter 10 having a length of 180 centimeters can beprovided with an extending main shaft 33 having a length of 120centimeters, to achieve the 300 centimeter total desired length forover-the-wire embodiments.

[0072] In another embodiment, where it is undesirable to have a longmain shaft extending proximally from catheter 10, a main shaft extendingproximally only several centimeters may be provided. The shorter mainshaft may be provided with an attachment (not shown), which is adaptedto releasably secure longer extensions to the main shaft, such that itcan also be used to facilitate the use of catheter 10 as a guidewire forother catheters.

[0073] It is preferred that main shaft 33 have a larger diameter thanthe other portions of sealing member 30, to make it easier to applymoving forces to sealing member 30. Thus, a tapering region 31 may bedisposed between main shaft 33 and wire 32, to transition the outerdiameter of sealing member 30 from the larger diameter of main shaft 33to the smaller diameter of wire 32. For the embodiment illustrated inFIGS. 1-3, it is wire 32 which is slidably inserted through opening 23and into lumen 40. Accordingly, the outer diameter of wire 32 must beless than the inner diameter of lumen 40, so that wire 32 may beslidably accommodated therein. Moreover, in those embodiments where theend of wire 32 extends distally past inflation port 22 when the valve isin the open position, the gap between the outer diameter of wire 32 andthe inner diameter of lumen 40 must be sufficiently large so as not tosignificantly restrict the flow of fluid passing through lumen 40 to orfrom inflation port 22. Optimally, to facilitate the sliding of wire 32within lumen 40 and to permit inflation fluid flow, wire 32 is fromabout 0.001 inches to about 0.004 inches smaller in outer diameter thanthe inner diameter of lumen 40.

[0074] In a preferred embodiment, wire 32 and catheter 10 are providedwith positive stops to prevent the withdrawal of wire 32 from theproximal end of catheter 10. For the embodiment depicted in FIGS. 3A and3B, this consists of a pair of cooperating annular rings mounted on wire32 and lumen 40, respectively. A first annular ring 34 is coaxially andfixedly mounted on wire 32 at a point on wire 32 contained within lumen40. A second corresponding fixed annular ring 35 projects inwardly fromthe interior surface of lumen 40 near proximal end 12. The innerdiameter of the opening of annular lumen ring 35 is slightly larger thanthe outer diameter of wire 32, so as not to restrict the movement ofwire 32 within lumen 40. However, the outer diameter of annular wirering 34 is greater than the inner diameter of the opening of ring 35,such that rings 34 and 35 cooperate to prevent wire 32 from beingwithdrawn from the proximal end of catheter 10.

[0075] Rings 34 and 35 may be formed of any material which may beattached to wire 32 and lumen 40, respectively, and which possessessufficient structural rigidity to act as a stop. Examples of suitablematerials are metals and various hard polymers, such as stainless steeland TEFLON (TM). In one preferred embodiment, where wire 32 and tubularbody 18 are both formed of nitinol, rings 34 and 35 are also formed ofnitinol and are soldered to wire 32 and the inner surface of lumen 40,respectively.

[0076] As will be appreciated by those of skill in the art, cooperatingstopping structures other than those described herein may also be usedto prevent full withdrawal of wire 32 from catheter 10. For example,annular ring 34 may be replaced by one or more protrusions extendingradially outwardly from wire 32, which are also adapted to cooperatewith ring 35 to prevent withdrawal of wire 32. Alternately, annular ring35 might be replaced by crimping tubular body 18 slightly to restrictmovement of ring 34 to points proximal of the crimp.

[0077] A lumen sealer portion 36 is coaxially and fixedly mounted onwire 32. Sealer portion 36 is positioned on wire 32 at a point distal toring 34, such that by partial withdrawal of wire 32 from catheter 10, asdepicted in FIG. 3A, sealer portion 36 is capable of being positionedwithin lumen 40 at a point proximal to inflation port 22. Sealer portion36 is also located on wire 32 at a point such that when wire 32 is fillyinserted into lumen 40, as depicted in FIG. 3B, sealer portion 36 eitherfilly covers inflation port 22, or is located within lumen 40 at a pointdistal to inflation port 22. The leading edge 36 a and trailing edge 36b of sealer portion 36 are preferably tapered, so that the edges ofsealer portion 36 do not catch upon inflation port 22 when sealerportion 36 passes by port 22.

[0078] It is preferred that sealer portion 36 form a fluid tight sealwith the outer diameter of wire 32 and the inner diameter of lumen 40,such that fluid in lumen 40 is prevented from flowing past sealerportion 36. In the embodiment illustrated in FIGS. 3A and 3B, this isachieved by providing wire 32 with a sealer portion 36 that firmlycontacts the entire inner circumference of a section of lumen 40 along asubstantial portion of the length of sealer portion 36. The fit betweenthe outer surface of sealer portion 36 and the inner surface of lumen 40is tight, such that a fluid tight seal is created which prevents fluidfrom passing past sealer portion 36. However, sealer portion 36 must becapable of being moved within lumen 40 upon movement of main shaft 33,tapering region 31, and wire 32. Thus, the fit between sealer portion 36and lumen 40 must not be so tight as to prevent movement of sealerportion 36 in lumen 40 upon application of sufficient longitudinal forceon main shaft 33. Moreover, the fluid tight seal created by the fitbetween lumen 40 and sealer portion 36 must be maintained as sealerportion 36 is moved back and forth within lumen 40.

[0079] Sealer portion 36 must also be capable of maintaining a seal atfluid pressures conventionally used to inflate catheter balloons, andshould be capable of maintaining a seal at pressures which exceedconventional inflation pressures. Preferably, sealer portion 36 iscapable of maintaining a seal at pressures up to about 10 atmospheres,more preferably pressures up to about 30 atmospheres, and mostpreferably at pressures up to about 60 atmospheres. Sealer portion 36 isalso preferably capable of undergoing multiple valve-opening andvalve-closing cycles without losing the structural integrity required toform seals capable of withstanding pressures of from about 10atmospheres to about 60 atmospheres. Optimally, sealer portion 36 iscapable of undergoing at least 10, and preferably at least 20,valve-opening and closing events and still be capable of maintaining afluid tight seal at a pressure of 10 atmospheres.

[0080] In one embodiment, the desired properties of sealer portion 36are attained by forming sealer portion 36 out of an extruded polymerictubing. PEBAX (TM) tubing having an inner diameter of 0.008 inches andan outer diameter of 0.017 inches, and a hardness of 40 durometers, isfirst necked by heating the extruded tubing to a temperature of between210 and 250 degrees Fahrenheit. Tube pieces of about 0.5 mm in lengthare then cut from the larger tubing. The cut PEBAX (TM) tubes are thenplaced on a nitinol wire having an outer diameter of about 0.006 inches,and are heated and shaped to recover a tube that has an outer diameterof between 0.010-0.011 inches. The adhesive LOCTITE 4014 (TM) may thenbe used to bond the heat-shaped PEBAX (TM) tubing to the nitinol wire.When the adhesive dries, the leading and trailing edges of the boundPEBAX (TM) seal may be trimmed, leaving an annular lumen contact lengthof about 0.010 inches (0.25 mm). The wire bearing the PEBAX (TM) sealerportion may then be inserted into the opening of a nitinol catheterhaving a lumen with an inner diameter of about 0.0096 inches. Sealerportions of this type have been observed to hold pressures of up to 30atmospheres, and are capable of undergoing multiple valve-opening andclosing events without significantly diminishing the seal strength.

[0081] As will be appreciated by those of skill in the art, differentforms of PEBAX (TM) starting materials may be used to form sealerportion 36. For example, in another preferred embodiment, similar stepswere used with a PEBAX (TM) tube having similar dimensions but ahardness of 70 durometers, to create a sealer portion.

[0082] It is contemplated by the present inventors that methods andmaterials other than those described above may be used to make a lumensealer portion having the desired properties. For example, materialsother than PEBAX (TM), silicone, latex rubber, C-FLEX (TM), NUSIL (TM)and gels, which are known to possess adequate surface properties tofunction as a sealer portion, and also be lubricous enough to be movedwithin lumen 40, may also be used to form sealer portion 36. Inaddition, sealer portion 36 may be attached to wire 32 by alternatemeans, such as by integrally molding sealer portion 36 to wire 32, dipforming sealer portion 36 to wire 32, as well as other means ofattaching a polymeric material to a wire known to those of skill in theart.

[0083] Other embodiments of sealer portion may not create a completelyfluid tight seal between the sealer portion and the inner lumen atballoon inflation pressures. In these embodiments, however, the sealerportion creates a seal which prevents substantially all inflation fluidflow past the sealer portion, such that the inflatable occlusive deviceis maintained in an almost fully expanded state for extended periods ofat least one minute, preferably 2 or more minutes, more preferably atleast 10 minutes, and optimally at least 20 minutes or longer, and stillbe capable of providing clinically effective occlusion of any emboliparticles in the blood vessel during this time period.

[0084] In a preferred embodiment, there is provided movement-forceincreasing structure, to increase the force required to move sealerportion 36 from the valve-closed to the valve-open position. Structureof this type advantageously minimizes the risk of an accidental openingof the valve, and subsequent balloon deflation, during a medicalprocedure. In the embodiment illustrated in FIGS. 3A and 3B, this isachieved by providing a biasing spring 37, which surrounds wire 32between stops 34 and 35. Spring 37 exerts a force on stop 34, pushingit, and thus wire 32 and sealer portion 36, in the distal direction, sothat sealer portion 36 forms a fluid tight seal by either covering port22 or by being positioned within the lumen at a point distal to port 22.Consequently, in the absence of a competing force, spring 37 maintainssealer portion 36 in the valve-closed position. Sealer portion 36 may bemoved proximally to the valve-open position by application of alongitudinal force on main shaft 33 directed proximally from end 12 ofsufficient magnitude to overcome the force of spring 37. Optimally,spring 37 is selected so that the force that must be applied to mainshaft 33 to overcome the force of spring 37 is from about 0.3 to about1.0 pound-foot. In alternative embodiments, the movement forceincreasing structure may comprise waves introduced into the wire justproximal of the sealer portion, as described below, which also mayrequire 0.3 to 1.0 pound-foot of force to overcome.

[0085] Referring to FIGS. 4 and 5, there is illustrated in alternativeembodiment of the valve of the present invention. The alternativeembodiment comprises a catheter 110 which may have features which aresubstantially identical, in materials, structure, and function, as thecatheter described in connection with FIGS. 1-3. Catheter 110 has aproximal end 112, and a distal end (not shown) to which is mounted anexpandable member, such as an inflatable balloon. A central lumen 140extends within tubular body 118 between the proximal and distal ends. Anopening 123 to lumen 140 is present at the proximal end 112 of catheter110.

[0086] A sealing member 130 is inserted into lumen 140 through opening123, as described previously. Sealing member 130 comprises a sealerportion 136, a wire 132, annular rings 134 and 135, and support member150. Sealing member 130 may be formed out of materials and by methods asdescribed previously.

[0087] As illustrated in FIGS. 4 and 5, the outer diameter of wire 132is less than the inner diameter of lumen 140, such that sealing member130 is sidably insertable into lumen 140. Furthermore, a lumen sealerportion 136 is coaxially and fixedly mounted to wire 132 near the distalend of wire 132. Sealer portion 136 forms a fluid tight seal with theouter diameter of wire 132 and the inner diameter of lumen 140, suchthat fluid introduced into lumen 140 through opening 122 is preventedfrom flowing past sealer portion 136 at normal balloon inflationpressures of 1 to 3 atmospheres for occlusive devices, and as much at 10atmospheres or more for other types of balloons. Sealer portion 136 maybe provided with leading edge 136 a and trailing edge 136 b, bothtapered, to facilitate movement of sealing portion 136 proximally anddistally of inflation port 122. Sealer portion 136 forms a fluid tightseal by firming contacting the entire inner circumference of a sectionof lumen 140 along a substantial portion of the length of sealer portion136. As described previously, sealer portion 136 prevents substantiallyall fluid flow past the seal created by sealer portion 136, and themovement of sealer portion 136 proximally and distally of port 122 maybe used to effect the valve-open and valve-closed positions.

[0088] Cooperating positive stops, consisting of hollow cylinders 134and 135 are provided to prevent withdrawal of sealing member 130 fromlumen 140. Hollow cylinder 135 is attached to the inner surface of lumen140 by adhesives, soldering, crimping, or by other means known to thoseof skill in the art, such that the proximal portion of hollow cylinder135 extends within lumen 140, and is secured therein, and the distalportion of cylinder 135 extends from proximal end 112. Cylinder 135 hasa lumen (not shown) extending therethrough. The diameter of the cylinderlumen is larger than the outer diameter of wire 132, so that movement ofwire 132 is not restricted. A second hollow cylinder 134, preferably ofshorter length, is placed over wire 132 and is fixedly mounted to wire132, by soldering, or other means, at a point distal to cylinder 135.The outer diameter of cylinder 134 is less than the inner diameter oflumen 140, so as not to restrict the movement of wire 132 within lumen140. However, the outer diameter of cylinder 134 is greater than theinner lumen diameter of cylinder 135, so that cylinders 134 and 135 actas cooperating stops, to prevent wire 132 from being withdrawn fromlumen 140. Cylinders 134 and 135 may be formed of any material which maybe attached to wire 132 and lumen 140, respectively, and which possessessufficient structural rigidity to act as a stop. Examples of suitablematerials are metals and various hard polymers, such as stainless steel,TEFLON (TM), and the like. In one preferred embodiment, where wire 132and tubular body 118 are both formed of nitinol, cylinders 134 and 135are also formed of nitinol, and are soldered to wire 132 and the innersurface of lumen 140, respectively.

[0089] The distal portion of cylinder 135 extending from proximal end112 is inserted into support member 150. Support member 150 comprises atubular body 158 having an outer diameter and inner lumen diameter whichare approximately the same as tubular body 118. Consequently, becausethe outer diameter of cylinder 135 is less than the inner lumen diameterof support member 150, the extending portion of cylinder 135 is slidablydisposed within the support member 150 inner lumen.

[0090] Wire 132 extends proximally from cylinder 135 within supportmember 150, as shown in FIGS. 4 and 5. A segment of wire 132 withinsupport member 150 is secured to support member 150 at point 152. Wire132 may be secured to support member 150 by any means known to those ofskill in the art, including use of adhesives, crimping, soldering orwelding. Because wire 132 is secured to support member 150, theapplication of longitudinal forces on support member 150 results inmovement of sealing member 130 within lumen 140, to open or close thevalve of the present invention, as described above with respect to FIGS.1-3. Advantageously, use of support member 150 protects wire 132 fromundesirable kinking or bending when sealing member 130 is moved.

[0091] As illustrated in FIGS. 4 and 5, sealing member 130 hasmovement-force increasing structure which increases the force requiredto move sealing member 130 within lumen 140. The movement-forceincreasing structure consists of waves 138 formed in wire 132 justproximal to sealer portion 136. Waves 138 contact the inner surface oflumen 140, thereby increasing the frictional forces which must beovercome to move wire 132 within lumen 140. In one preferred embodiment,where wire 132 is made of nitinol and has an outer diameter of 0.006inches, and is inserted into a nitinol catheter which has an inner lumen140 with the diameter of about 0.010 inches, waves are forned on wire132 for one and one-half cycles with an amplitude of about 0.016 inchesto increase the valve- opening movement force.

[0092] Referring to FIGS. 6 and 7, there is illustrated anotherembodiment of the present invention. Referring to FIG. 6, there isprovided a catheter 400 having a tubular body 418 and inflatable balloon(not shown) as described above. Catheter 400 may be formed of materialsand methods as described above, and may have structural aspectsidentical to those described previously, except where otherwise noted.In particular, as shown in FIGS. 6 and 7, catheter 400 is not providedwith a side-access port on the catheter tubular body, nor is thereprovided cooperating positive stops on the wire and lumen. Instead, thesealer portion may be fully withdrawn from the lumen. Once the sealerportion is removed, the proximal opening serves as an access port forattached devices to inflate or deflate the balloon. The sealer portioncan be inserted through the proximal opening into the lumen afterballoon inflation to maintain the balloon in the inflated state.

[0093] Catheter 400 has a proximal end 412, and a distal end (not shown)to which is mounted an inflatable balloon. A central lumen 440 extendswithin tubular body 418 between the proximal and distal ends. An opening423 to lumen 440 is present at the proximal end 412 of catheter 400.

[0094] A sealing member 430 is inserted into lumen 440 through opening423. Sealing member 430 has a main shaft 433, a tapering region 431, anda wire 432. Sealing member 430 may be formed of materials and by methodsas described previously. As illustrated in FIGS. 6 and 7, the outerdiameter of main shaft 433 is less than the inner diameter of lumen 440,such that main shaft 433 is slidably insertable into lumen 440. Inaddition, the outer diameters of tapering region 431 and wire 432 arealso smaller than main shaft 433, and thus lumen 440, such that taperingregion 431 and wire 432 are also slidably insertable in lumen 440. Aportion of main shaft 433 preferably extends proximally from end 412, tofacilitate application of moving forces upon sealing member 430 to movewire 432 within lumen 440, as described previously.

[0095] As illustrated in FIGS. 6 and 7, sealing member 430 hasmovement-force increasing structure which increases the force requiredto move sealing member 430 within lumen 440. The movement-forceincreasing structure consists of waves 438 a and 438 b formed in wire432 near its distal end. Waves 438 a and 438 b contact the inner surfaceof lumen 440, thereby increasing the frictional force which must beovercome to move wire 432 within lumen 440. In one preferredembodirnent, where wire 432 is made of nitinol and has an outer diameterof 0.006 inches, and is inserted into a nitinol catheter which has aninner lumen 440 with a diameter of about 0.010 inches, waves are formedon wire 432 for 1½ cycles with an amplitude of about 0.016 inches toincrease the valve-opening movement force.

[0096] A lumen sealer portion 436 is coaxially and fixedly mounted onwire 432. Sealer portion 436 forms a fluid tight seal with the outerdiameter of wire 432 and the inner diameter of lumen 440, such thatfluid introduced into lumen 440 through opening 423 is prevented fromflowing past sealer portion 436 when sealer portion 436 is inserted intolumen 440. Sealer portion 436 forms the fluid tight seal by firmlycontacting the entire inner circumference of a section of lumen 440along a substantial portion of the length of sealer portion 436, and maybe formed of materials and by methods as previously described.

[0097] In some removable sealing member embodiments, the sealing memberis not provided with a separate sealing portion, as described above. Inthese embodiments, the sealing member itself functions as a sealingportion which is inserted into the proximal opening to restrict fluidflow, and which may be partially or wholly removed to provide for afluid pathway between the proximal opening and an expandable member onthe distal end of the catheter. Preferably, the sealing members of theseembodiments comprise a tapering rod, which at its distal end, has anouter diameter smaller than the inner lumen diameter of the catheter inwhich it is inserted as a plug, such that the distal end of the rod maybe easily inserted into the catheter lumen through the proximal opening.The tapering rod increases in outside diameter at points proximal to thedistal end. Consequently, one or more points of the rod have an outsidediameter greater than the inner lumen diameter of the catheter in whichit is inserted as a plug, such that by forcing the rod into proximalopening, the larger outer diameter of the rod forms a relatively fluidtight seal with the catheter lumen at the proximal opening of thecatheter. An O-ring, or other polymeric structure, may be mounted in theinner lumen of the catheter at or near the proximal opening, tocooperate with the tapering rod in the creation of the seal. Thus, inthis embodiment, the point where the seal is created does not move withrespect to the catheter, but is instead stationary at or near theproximal opening of the catheter.

[0098] Referring to FIG. 12, there is depicted an alternative embodimentof the valve the present invention. The alternative embodiment isprovided to a catheter 500, formed of a tubular body 518 and having aproximal end 512. Catheter 500 has an opening 523 at is proximal end,and a lumen 540 extending the length of the tubular body. Lumen 540 isin fluid communication with an expandable member (not shown) mounted onthe distal end of tubular body 518. A side-access port 522 is providedin tubular body 518 at a point distal to proximal end 512. Catheter 500may have aspects identical, both in structure, dimensions, materials,and construction, to catheters described previously.

[0099] A sealing member 550 is positioned within lumen 540 near proximalopening 523 and side-access port 522. Sealing member 550 is formed froma short tubular body 568, having a lumen 590, which is sealed at end562, but open at the other end. Sealing member 550 has an outer diameterslightly larger that the inner diameter of lumen 540, but smaller thanthe outer diameter of tubular body 518, such that sealing member 550 maybe tightly fit within lumen 540 through opening 523, to form a fluidtight seal over catheter proximal opening 523. Cooperating stoppingstructures (not shown) may be provided to sealing member 550 andcatheter 500 to prevent removal of sealing member 550 from lumen 540 atelevated pressures. Sealing member 550 may be formed out of the samematerials as tubular body 518.

[0100] Tubular body 568 is provided with an opening 572 extendingtherethrough. Opening 572 is positioned on tubular body 568 such thatopening 572 is capable of aligning with side-access port 522 whensealing member 550 is rotated within lumen 540, or is moved proximallyor distally within lumen 540. A rotation element 595, such as aperpendicular attachment, may be provided facilitate rotation of sealingmember 550 within lumen 540. Other rotation elements, such as notches orgrooves, may be used in place of the perpendicular attachment, as willbe appreciated by those of skill in the art.

[0101] Sealing member 550 functions as a valve within catheter 500,controlling fluid flow through side-access port 522. When sealing member550 is rotated so that port 522 and opening 572 are aligned, fluid mayflow through port 522 through lumen 540 to inflate the occlusive device.Upon the desired inflation, sealing member 550 may be rotated, as forexample by ninety degrees, or moved proximally or distally within lumen540, such that opening 572 is no longer aligned with port 522, andtubular body 568 blocks fluid flow through port 522.

[0102] Shown in FIG. 13, is an alternative embodiment of the rotatablesealing member. Numerals corresponding to those of the embodiment ofFIG. 12 have been used to illustrate the similar structural aspectsbetween the two embodiments. Sealing member 600 is identical inconstruction to the sealing member of FIG. 12, except that sealingmember 650 is somewhat larger, and is adapted to be slipped over tubularbody 618. The respective diameters of tubular body 618 and sealingmember lumen 690 are such that a fluid tight seal is created over lumen623. Side-access inflation port 622 may be aligned with opening 672, asabove, by rotation or longitudinal movement, to provide fluid access tolumen 640 through port 622.

[0103] In certain embodiments, it may be desirable for sealing members550 and 650 to have a longer length, such that they may function as anextension for other catheters to be inserted over catheters 500 and 600.In these embodiments, sealing members 550 and 650 may be formed withlonger tubular bodies, or be provided with attachments so that extensionmembers may be releasably secured thereto.

[0104] Referring to FIGS. 14, 15A and 15B, there is illustrated analternative embodiment of the present invention featuring a self-closingvalve. The alternative embodiment comprises a catheter 700 having anelongate flexible tubular body 718 extending between a proximal controlend 712 and a distal functional end (not shown), and having a balloon(not shown) as described previously. Tubular body 718 has central lumen740 which extends between the proximal and distal ends. Lumen 740 has anopening 723 at proximal end 712, and is sealed fluid tight at the distalend. A side access inflation port 722 is formed in tubular body 718 at apoint distal of opening 723. Inflation port 722 and lumen 740 are influid communication with the distal inflatable balloon, as describedpreviously.

[0105] A wire 732 is inserted into opening 723, and is slidably disposedwithin lumen 740. Accordingly, the outer diameter of the wire 732 mustbe less than the inner diameter of lumen 740, so that wire 732 may beslidably accommodated therein. A sealer portion 736 is coaxially mountedon wire 732. Sealer portion 736 is of similar type and construction tothe sealer portion described in connection with FIGS. 1-3. Sealerportion 736 is positioned on wire 732 at a point distal to inflationport 722, and forms fluid-tight seal with the outer diameter of wire 732and the inner diameter of lumen 740, such that fluid introduced intolumen 740 is prevented from flowing past sealer portion 736.Consequently, because sealer portion 736 is positioned with lumen 740distal to inflation port 722, sealer portion 736 is in the valve-closedposition.

[0106] In the embodiment depicted in FIGS. 14-15B, tubular body 718 isformed from a material having a certain degree of elasticity, such thatif the proximal end 712 of tubular body 718 is secured to wire 732 atpoint 750, and a longitudinal force is applied to tubular body 718 in adirection distal to end 712, the elasticity of tubular body 718 resultsin the shifting of inflation port 722 in the distal direction. Moreover,slits 711 may be formed in tubular body 718 near proximal end 712 toenhance the elastic response of tubular body 718, thereby increasing thedistal translocation of inflation port 722 upon application of an axialforce to tubular body 718. Wire 732 may be secured to tubular body 718by any means known to those of skill in the art, such as adhesives,welding, soldering, or crimping.

[0107] In a preferred embodiment, tubular body 718 is made out ofnitinol, and has at least 8% elasticity when longitudinal slits 711 areintroduced at the proximal end. As can be observed in FIG. 15A, in theabsence of any longitudinal force applied to tubular body 718, sealerportion 736 is positioned within lumen 740 at a point distal toinflation port 722, such that fluid may not pass through port 722 toinflate or deflate the balloon. However, if a longitudinal force isapplied to tubular body 718 in the distal direction, and the proximalend of tubular body 718 and wire 732 are held in position, tubular bodywill stretch, as shown in FIG. 15B, and inflation port 722 will betranslocated in the distal direction so that sealer portion 736 will belocated within the lumen proximally of port 722. This will establish anunrestricted fluid pathway between inflation port 722 and the distalballoon, so that the balloon may be either inflated or deflated bypassage of fluid through port 722. Upon removal of the longitudinalforce, the elastic response of tubular body 718 will result in proximaltranslocation of inflation port 722, and sealer portion 736 will onceagain be in the valve-closed position.

[0108] Referring to FIGS. 8 and 9A, there is illustrated an inflationadaptor 200 which may be used to inflate and to open and close the lowprofile valve depicted in FIGS. 1-5. Inflation adaptor 200 comprises ahousing having a first half 202 and a second half 204, which arepreferably formed of metal, medical grade polycarbonate, or the like.Halves 202 and 204 are attached to one another by a pair of hinges 205positioned on one of the lateral edges of each half, such that halves202 and 204 may be separated or joined in a clam shell manner asdepicted in FIGS. 8 and 9. A locking clip 230 secures half 202 to half204 while inflation adaptor 200 is in use. Locking clip 230 may beprovided with an angled leading edge 235 to facilitate closing of clip230 to secure halves 202 and 204 together. Springs 209 may also beprovided to facilitate opening of adaptor 200.

[0109] A groove 240 separates first half 202 from second half 204 whenthe halves are closed and clip 230 is secured. Groove 240 is ofsufficient width to accept the proximal end of a catheter having the lowprofile valve of the present invention, as described in detail above. Afitting 210 is positioned on half 202, to create an inflation passageway212 which terminates in opening 285 on the interior surface of firsthalf 202. Fitting 210 is preferably a standard luer connector which maybe attached to a variety of existing external pressurized fluid sources,although other types of fittings, such as tubings, quick connects, andY-site connections, may be easily substituted for a luer fitting.

[0110] A seal comprising a pair of gaskets 280 is positioned aroundopening 285 on the interior surfaces of halves 202 and 204. Gaskets 280are in alignment, such that when halves 202 and 204 are brought togetherand secured by locking clip 230, a fluid tight inflation chamber iscreated within the interior region defined by gaskets 280. The fluidtight inflation chamber is in fluid communication with fitting 210 viainflation passageway 212, so that a pressurized inflation fluid may beintroduced into the fluid tight inflation chamber by attaching anexternal pressurized fluid source to fitting 210. Moreover, gaskets 280are preferably formed of resilient materials, such as silicone, C-FLEX(TM) and PEBAX (TM), so that gaskets 280 may form-fit over a cathetertubular body which extends across the lateral edges of gaskets 280, tocreate the fluid tight chamber.

[0111] An actuator 220 is positioned on the external surface of half202. In the embodiment illustrated in FIGS. 8 and 9, actuator 220controls a cam which operates a sliding panel 283 on the interiorsurface of half 202. Sliding panel 283 moves back and forth along a linewhich bisects opening 285. When actuator 220 is moved to a firstposition, sliding panel 283 moves toward opening 285 along this line.When actuator 220 is moved to a second position, sliding panel 283 movesaway from opening 285 along the same line. A corresponding sliding panel284 is positioned on half 204, such that panels 283 and 284 are alignedand move together when the position of actuator 220 is changed. Tofacilitate coordinated movement of panels 283 and 284, a pin 286, orsuch other similar engagement structure, may be provided to releasablysecure panel 283 to panel 284 when the adaptor is closed. The length oftravel of panels 283 and 284 is preferably adjusted to provide theminimum sufficient distance to position the sealing member in the valveopen or valve closed position, as desired.

[0112] Panels 283 and 284 each have a roughened surface 290, tofacilitate the frictional engagement of panels 283 and 284 with the mainshaft portion of the low profile valve. In a preferred embodiment,panels 283 and 284 are both made of silicone, and roughened surface 290comprises teeth 291 and grooves 292 formed on each of panels 283 and284. The teeth 291 and grooves 292 cooperate, to permit the teeth of onepanel to fit into the grooves of the opposite panel when the adaptor isclosed.

[0113] For ease of understanding, the operation of inflation adaptor 200to inflate the balloon of the catheter of FIGS. 1-3 will now bedescribed. Actuator 220 is moved to the first position, so that slidingpanels 283 and 284 are moved closer to opening 285. Locking clip 230 isthen undone, exposing groove 240. Halves 202 and 204 are then partiallyseparated, and catheter 10, with the balloon 20 deflated, is insertedinto the inflation adaptor. As described previously, catheter 10 has aninflation port 22 located near proximal end 12, and a main shaft 33extending from proximal end 12. Catheter 10, with the low profile valvein the closed position, is placed within groove 240 of partially openadaptor 200, and catheter 10 and main shaft 33 are placed withinsecuring clips 271 and 272, such that when halves 202 and 204 areclosed, inflation port 22 will lie within the fluid tight inflationchamber created by gaskets 280, and the extending portion of main shaft33, but not proximal end 12, will rest between sliding panels 283 and284. An alignment slot 298 and overlying shelf 299 may be provided tofacilitate alignment and prevent buckling or kinking of the catheter andsealing member during use.

[0114] As shown in FIG. 9B, in one embodiment, indicia 260 are providedon catheter 10 and main shaft 33, which when aligned with indicia 270 oninflation adaptor 200, result in alignment of inflation port 22 with thefluid tight inflation chamber of adaptor 200, and alignment of mainshaft 33 with sliding panels 283 and 284, when catheter 10 and sealingmember 30 are inserted into groove 240. Indicia 260 and 270 may take theform of markings, grooves or notches, or any other suitable means ofaligning the valve with the inflation adaptor alignment indicia, may beprovided. Preferably, the gap between indicia 260 on catheter 10 andmain shaft 33 is approximately equal to the space between clips 271 and272, such that by placing indicia 260 within clips 271 and 272, catheter10 and main shaft 33 are properly aligned within adaptor 200.

[0115] Indicia solely on the catheter tubular body may also be used tofacilitate correct alignment. For example, two visible markings may beplace on the catheter on either side of the catheter inflation accessport. By inserting the catheter into lower half 204 so that both ofthese markings are place within lower half gasket 280, the catheterinflation access port will be within the fluid tight inflation chambercreated by gaskets 280 when halves 202 and 204 are secured to oneanother.

[0116] Once main shaft 33 and inflation port 22 are properly alignedwithin adaptor 200, locking clip 230 is secured. Inflation port 22 nowlies within the fluid tight inflation chamber created by gaskets 280,and main shaft 33 rests between sliding panels 283 and 284. Theclinician may then attach an external pressurized fluid source tofitting 210.

[0117] To inflate balloon 20, the clinician moves actuator 220 from thefirst position to the second position, thereby causing sliding panels283 and 284 to move away from opening 885. Because main shaft 33 isfirmly secured between panels 283 and 284, a longitudinal force directedaway from proximal end 12 is applied to main shaft 33. The longitudinalforce on main shaft 33 results in wire 32 being partially withdrawn fromlumen 40, which causes sealer portion 36 on wire 32 to be moved to aposition within lumen 40 which is proximal of inflation port 22. Themovement of sealer portion 36 proximally of inflation port 22 opens thelow profile valve, by establishing an unrestricted fluid pathway betweeninflation port 22 and balloon 20.

[0118] The external pressurized fluid source may then be activated, asfor example by pushing the plunger on a syringe, such that pressurizedfluid passes through passageway 212 and opening 285 into the fluid tightinflation chamber. The pressurized fluid then passes through inflationport 22 and lumen 40, to inflate balloon 20.

[0119] Inflated balloon 20 may be maintained in the inflated state, inthe absence of the pressurized fluid source, by closing the low profilevalve. This is accomplished by moving actuator 220 back to the firstposition, thereby causing sliding panels 283 and 284 to move towardopening 285. The moving panels apply a longitudinal force, directedtoward proximal end 12 to main shaft 33, causing wire 32 to be furtherinserted into lumen 40. Consequently, sealer portion 36 is moved from aposition within lumen 40 which is proximal to inflation port 22 to aposition in lumen 40 which is distal to inflation port 22. The fluidtight seal created by sealer portion 36 traps the pressurized fluidwithin lumen 40 and balloon 20, thereby maintaining balloon 20 in theinflated state. The external pressurized fluid source may then bedeactivated and removed. Once the low profile valve is closed, inflationadaptor 200 may be removed by unlocking clip 230, and removing catheter10 and main shaft 33 from groove 240.

[0120] Referring to FIGS. 10 and 11, there is illustrated an alternativeembodiment of an inflation adaptor especially adapted for manipulatingremovable low profile valves, although it may be used with side-accessembodiments as well. Moreover, it should also be appreciated thatadaptor 200 and similar type adaptors may also be used to manipulateremovable valve embodiments.

[0121] Adaptor 300 comprises an outer sleeve 320 formed of metal,medical grade polycarbonate, or similar such materials. Outer sleeve 300defines a tapering inner lumen 350. Lumen 350 tapers from large diameter352 which is significantly greater than the outer diameter of thecatheter tubular bodies inserted into lumen 350, to a smaller diameter355, which is slightly larger the outer diameter of the catheter tubularbody. Lumen 350 is in fluid communication with an inflation passageway312 formed by fitting 310, so that a pressurized inflation fluid may beintroduced into lumen 350. Releasable seals 315 are positioned at eachend of lumen 350, such as to create a fluid tight inflation chamberwithin lumen 350 when a pressurized fluid source is attached. Releasableseals 350 may comprise any type of seal known to those of skill in theare, such as Toughy Borst connectors, hemostatic valves, and the like.Releasable seals 350 may also act to secure any catheters and sealingmembers inserted within the releasable seal openings 325 In use, acatheter and sealing member, such as that described in connection withFIGS. 6-7, is inserted into opening 325 after seals 315 have beenopened. The catheter and sealing member are positioned under passageway312, and the sealing member is removed from the proximal opening of thecatheter. A fluid passageway is thereby created between the proximalcatheter opening and the expandable member of the distal end of thecatheter. Seals 350 are closed to create a fluid tight chamber, and avacuum and/or pressurized inflation fluid is applied, to inflate ordeflate the balloon. After the desired inflation or deflation hasoccurred, the sealing member may be introduced into the proximal openingof the catheter tubular body to seal the lumen, either by hand or by amovable actuator (not shown). Seals 350 may then be loosened, and theend access adaptor 300 removed by sliding the adaptor off the end of thecatheter and sealing member.

[0122] Referring to FIGS. 16-18B, there is illustrated an alternativeembodiment inflation adaptor 800 which may also be used in conjunctionwith the low profile valves of the present invention, of the typedepicted in FIGS. 1-5, to inflate or deflate catheter balloons.Inflation adaptor 800 comprises a housing having a first half 802 and asecond half 804, which are preferably formed of a medical gradepolycarbonate. However, as will be appreciated by those of skill in theart, a great many other materials may by used to form adaptor 800,including metals such as 300 series stainless steel and 400 seriesstainless steel, and polymeric materials such asAcrylonitrile-butadiene-styrene (ABS), Acrylics, andStyrene-acrylonitriles. Furthermore, the individual halves 802 and 804may be manufactured in a variety of different ways. For example, wherepolymeric materials are used, it is preferable to use a mold tomanufacture each of the halves. Moreover, in some embodiments, more thanone molded piece may be used to form an individual half, with thevarious pieces being joined together by bonding or mechanical means toform a half. Alternately, as is known in the art, the individual halvescan be formed through machining processes performed on larger blocks ofthe raw materials.

[0123] Halves 802 and 804 are attached to one another by hinges 806positioned on one of the lateral edges of each half, through which ajoining pin 805 is inserted, such that halves 802 and 804 may be openedor closed in a clam shell manner as depicted in FIGS. 16 and 17.Preferably, the cross-sectional angle formed by halves 802 and 804 inthe open position, as shown in FIG. 17, is 90° or greater, and morepreferably from 120°-180°, to facilitate insertion of a catheter intoadaptor 800.

[0124] As shown in FIGS. 16 and 17, a plate 832 is secured to the frontportion of housing half 804 by three screws 833. Plate 832 is providedwith two or more pin receptacles 834. A cam latch 830 is mounted onplate 832 and is secured thereto by pin 831 which runs through pinreceptacles 834 and a corresponding cam latch pin receptacles 836, toform a hinge between cam latch 830 and plate 832. Cam latch 830 andplate 832 may be made from any of the same variety of materials ashousing halves 802 and 804, and for any particular embodiment, arepreferably made of identical materials, although combinations ofmaterials may also be used. Also, as is appreciated by those of skill inthe art, the corresponding hinge structure provided by plate 832 and camlatch 830 may also be achieved by many other methods. For example, plate832 may be integrally molded with housing half 804 at the time ofmanufacture as a single piece, thereby eliminating the need for screws833, but with cam latch 830 mounted thereon as described above.

[0125] Cam latch 830 is designed to secure halves 802 and 804 togetherwhen adaptor 800 is in use, to assist in the creation of an theinflation seal as described above. Advantageously, by placing cam latchon half 804 as shown, the adaptor interior is more accessible to theclinician during a procedure, and it is easier for the clinician toinsert catheters into adaptor 800. Cam latch 830 also serves theimportant function of preventing accidental opening of the adaptor 800during use. An important feature of cam latch 830 is the manner in whichit cooperates with housing half 802 to create a releasable lockingmechanism which applies great force to halves 802 and 804 upon closing,while at the same time using the principles of mechanical advantage tominimize the force the user must exert to close cam latch 830. This isachieved by providing latch 830 with a cammed surface 838 and alsoproviding the front edge of housing half 802 with a rounded lip 837 toaccept cammed surface 838, as shown in cross-sectional schematic form inFIGS. 19A-19C.

[0126] Referring to FIG. 19A, halves 802 and 804 have been broughttogether, with cam latch 830 in its open position. As cam latch 830begins to be closed, as shown in FIG. 19B, cammed surface 838 contactsrounded lip 837 and exerts a closing force thereon. Upon furtherclosing, and to the fully closed position shown in FIG. 19C, cam latch830 acts as a lever, with the closing force between cammed surface 838and lip 837 being a function of the force of exerted by the user, thelength of the lever (length of cam latch door), and the height of thecam surface, as defined by the following well known mathematicalequation: $F_{u} = {F_{c}\frac{H}{L}}$ $\begin{matrix}{F_{u} = {{User}\quad {applied}\quad {force}}} \\{F_{c} = {{Closing}\quad {force}}} \\{L = {{length}\quad {of}\quad {lever}\quad \left( {{width}\quad {of}\quad {door}} \right)}} \\{H = {{height}\quad {of}\quad {cam}}}\end{matrix}$

[0127] However, as can be appreciated, because the lever length, whichin the adaptor embodiment is the length of cam latch 830 in its closingdirection, is much greater than the height of the cam created by surface838 and lip 837, the closing force exerted is always greater than theforce the user exerts on cam latch 830. Thus, very tight seals mayeasily be created by the clinician when the device is used.

[0128] Cam latch 830 is also preferably provided with a shelf 835 tosecure halves 802 and 804 together. Shelf 835 is positioned on latch 830at a point such that when latch 830 is in its closed position, shelf 835firmly contacts housing half 802 along the side bearing hinges 806.Preferably, shelf 835 has an angled leading edge to facilitate closingof latch 830.

[0129] A gap 840 separates first half 802 from second half 804 when thehalves are closed and latch 830 is secured. Gap 840 is of sufficientwidth to accept the proximal end of a catheter having the low profilevalve of the present invention, as described in detail above, withoutcrimping the catheter to impair its function. A fitting 810 ispositioned on half 802, to create an inflation passageway 812 whichterminates in opening 885 on the interior surface of first half 802.Fitting 810 is preferably a standard luer connector which may beattached to a variety of existing external pressurized fluid sources,although other types of fittings, such as tubings, quick connects, andY-site connections, may be easily substituted for a luer fitting.

[0130] A seal comprising a pair of gaskets 880 is positioned aroundopening 885 on the interior surfaces of halves 802 and 804. Gaskets 880are in alignment, such that when halves 802 and 804 are brought togetherand secured by cam latch 830, a fluid tight inflation chamber is createdwithin the interior region defined by gaskets 880. The fluid tightinflation chamber is in fluid communication with fitting 810 viainflation passageway 812, so that a pressurized inflation fluid may beintroduced into the fluid tight inflation chamber by attaching anexternal pressurized fluid source to fitting 810. Gaskets 880 arepreferably formed of resilient materials, such as silicone, C-FLEX (TM)and PEBAX (TM) or KRATON (TM), silicone, and other elastomericmaterials, so that gaskets 880 may form-fit over a catheter tubular bodywhich extends across the lateral edges of gaskets 880, to create thefluid tight chamber.

[0131] An actuator 820 is positioned on the external surface of half802. In the embodiment illustrated in FIGS. 16-18B, actuator 820 is arotatable knob controlling a cam which operates a sliding panel 883 onthe interior surface of half 802. As will be appreciated by those ofskill in the art, however, a great many different actuating structuresother than rotatable knobs and sliding panels may be used to achieve themovement of the catheter sealing members described herein. Furthermore,where catheter valves of the present invention require rotationalmovement, such as those of FIGS. 12 and 13, rotational actuatingmechanisms may be provided as well.

[0132] Sliding panel 883 moves back and forth along a line which bisectsopening 885. When actuator 820 is moved to a first position, shown inFIG. 18A, sliding panel 883 moves away from opening 885 along this line.When actuator 820 is moved to a second position, as shown in FIG. 18B,sliding panel 883 moves toward opening 885 along the same line. Acorresponding sliding panel 884 is positioned on half 804, such thatpanels 883 and 884 are aligned and move together when halves 802 and 804are closed and the position of actuator 820 is changed.

[0133] In actual clinical practice, the movement of panels 883 and 884results in the opening and closing of a catheter valve placed withinadaptor 800. When actuator 820 is moved to the position shown in FIG.18A, panels 883 and 884 move away from opening 885. This would result inthe opening of the valve described in connection with FIGS. 1-5, as thesealer portion of the valve would be positioned proximally of the accessport to establish a fluid pathway between the access port and theinflatable balloon at the distal end of the catheter. Conversely, whenactuator 820 is moved to the position shown in FIG. 18B, panels 883 and884 move toward opening 885. This would result in the closing of thevalve, as the sealer portion of the valve would be positioned distallyof the access port, thereby preventing substantially all fluid flowbetween the access port and those portions of the catheter distal to thesealer portion. Preferably, detents (not shown) are provided on theactuator camming mechanism to provide the user with tactile and audiblefeedback when the panels are nearest or farthest from opening 885 (i.e.,catheter valve is closed or open, respectively).

[0134] Adaptor 800 is also preferably provided with a safety lock, toprevent accidental opening when the adaptor is being used and thecatheter valve is open. As shown in FIG. 18A and 18B, this may beachieved by providing an extending flanged portion 822 to actuator knob820. When actuator knob 820 is in the valve open position, as shown inFIG. 18A, extending flange 822 extends over latch 830, preventing thelatch from being opened. In the valve closed position, as shown in FIG.18B, flange 821 is rotated away from latch 830, which may then beopened.

[0135] Panels 883 and 884 each have a roughened surface 890, tofacilitate the frictional engagement of panels 883 and 884 and theircoordinated travel with the moving portions of the low profile valve.Panels 883 and 884 may be made from any of a variety of polymeric ormetallic materials, but must possess sufficient frictional force toengage and move the catheter sealing member without slippage.Consequently, depending on the type of catheter used, those of skill inthe art may desire to select different materials for panels 883 and 884to maximize the frictional forces between the panels and their intendeduse catheter. In a preferred embodiment, in which panels 883 and 884 areto engage a catheter sealing member made from stainless steel, panels883 and 884 are both made of KRATON 90A (TM), and roughened surface 890comprises teeth 891 and grooves 892 formed on each of panels 883 and884. The teeth 891 and grooves 892 cooperate, to permit the teeth of onepanel to fit into the grooves of the opposite panel when the adaptor isclosed. Furthermore, alternative cooperating structure, such as dimplesand ridges, may also be used to coordinate travel of panels 883 and 884.

[0136] One problem that has been recognized with low profile valves ofthe present invention is the phenomenon of plug walk-out. That is, afterthe valve has been placed in its closed position, with the sealerportion of the sealing member distal to the inflation access port, andthe adaptor removed, the internal forces on the sealing member tend tocause very small portions of the sealing member to be pushed out of thecatheter proximal end. Plug walk out is undesirable as it has an adverseimpact on the ability of the sealed catheter to act as a guidewire forother devices. It has been found, however, the plug walk out can beminimized or eliminated if the sealing member is initially “overdriven”,or forced slightly further in the catheter, during the sealing step.

[0137] Advantageously, adaptor 800 is provided with an overdrive systemto overdrive a sealing member into a catheter. Referring to FIG. 17,panel 884 travels back and forth within housing recess 894 along a whichbisects opening 885, as described above. A spring 809 is mounted inrecess 894 and is attached to the wall of recess 894 and panel 884.Spring 809 is biased so as to push panel 884 toward opening 885, andforces panel 884 against the wall of recess 894 which is opposite tothat which spring 809 is attached.

[0138] Referring to FIGS. 20A-C, there is shown the top portion of half802 containing panel 883. Panel 883 resides in housing recess 893, andtravels back and forth along a line which bisects opening 885, asdescribed above. The movement of panel 883 is controlled by actuator820, as described above. An expanded spring 888 is attached to panel883, as shown in FIGS. 20A-C. Spring 888 has a strength which exceedsthat of lower spring 809. In the adaptor open position, as shown in FIG.17, expanded spring 888 contacts the wall of recess 893, and pushespanel 883 away from the recess wall to create an overdrive gap 886, asshown in FIG. 20A.

[0139] When a catheter with a valve in a closed position is loaded intohalf 804, and halves 802 and 804 are closed and latched, the teeth 891of panel 883 contact the grooves of panel 884. The superior spring forceof spring 888 then forces spring 809 to compress a small amount, suchthat panel 884 no longer is forced against the recess wall, and now hasan overdrive gap (not shown) approximately equal to overdrive gap 886.The actuator may then be engaged to drive panels 883 and 884 away fromopening 885 toward recess walls 893 a and 894 a, respectively, therebyopening the valve mechanism. The inflatable balloon on the catheter maythen be inflated as described above.

[0140] Upon closure of the valve, by rotating actuator 820 in theopposite direction, panels 883 and 884 are moved toward opening 885until the sealer portion of the sealing member is distal to the catheterinflation access port. Overdrive of the sealing member is then achievedwhen actuator 820 is adjusted so that panels 883 and 884 are forcedagainst recess walls 893 b and 894 b, as shown for panel 883 in FIG.20C. That is, the force of actuator 820 overcomes the force of spring888, and drives the sealing member into the catheter by a distancefarther than it initially resided before the valve was opened, thedistance being approximately equal to the width of gap 886. It has beenfound that by overdriving the sealing member to a closed positionfurther than its initial closed position compensates for plug walk-out.Preferably, the sealing member is overdriven by a distance of about0.020 inches.

[0141] Alternative overdrive mechanisms may be used for other adaptorembodiments. For example, rather than mounting spring 888 on panel 883,the spring might be mounted in a slot wall 893 b, with a plunger (notshown) attached to panel 883 and aligned with the spring. In itsunforced state, the spring would exert force on the plunger, pushingpanel 883 away from wall 893 a to create overdrive gap 896. However, asbefore, the actuator mechanism 820 could be used to overcome the springforce in the valve closing cycle, thereby creating the overdrive.Numerous other overdrive mechanisms may also be employed, as will beappreciated by those of skill in the art.

[0142] As illustrated in FIG. 17, adaptor 800 is also provided withimmovable pads 870 on both halves 802 and 804. Pads 870 function tosecure the catheter within adaptor 800 when it is closed, and to preventmovement of the catheter during valve opening and valve closingprocedures. Accordingly, the material used for pads 870 is selected tohave a high degree of frictional force with respect to the surface ofthe catheter body to which pads 870 will contact. A wide variety ofpolymeric and metallic materials are thus suitable to form pads 870 suchas KRATON (TM), C-FLEX (TM) or PEBAX (TM). In one embodiment, pads 870are integrally molded with halves 802 and 804 out of medical gradepolycarbonate, and are intended to contact a catheter tubular bodyformed from nitinol.

[0143] It is also preferred that half 804 be provided with guiding meansto facilitate correct positioning of the catheter into the adaptor. Forthe embodiment illustrated in FIG. 17, these guiding means consist oftwo or more clips 896 to facilitate positioning of a catheter into theadaptor. Clips 896 are provided with grooves 897 in which the catheteris inserted and secured prior to closure of adaptor 800. Clips 896 maybe formed of any material flexible enough to be capable of releasablysecuring the catheters to be used in adaptor 800. In one preferredembodiment, clips 896 are formed of C-FLEX 70A (TM). On half 802, andaligned with clips 896, there are provided recesses 895, to accept clips896 when halves 802 and 804 are brought together and closed. Preferably,alignment indicia on the catheters to be used with adaptor 800 coincidewith the spacing of clips 896, so that by placing the catheter portionbearing the indicia directly in clips 896, the catheter is properlyinserted in the adaptor with its inflation access port contained in thefluid tight inflation chamber created by gaskets 880 upon closure ofadaptor 800. A projecting ridge 875 may also be provided to facilitateplacement of the catheter, and direct its orientation during placementin the adaptor so that alignment is proper.

[0144] Alternately, other guiding means may be used as well. Forexample, clips 896 may comprise one or more magnetic elements whichcooperate with gold-plated stainless steel rings (or other platedferromagnetic substances) incorporated into the catheter tubular body toguide the catheter into the correct alignment position.

[0145] In one preferred embodiment, as shown in FIG. 17, halves 802 and804 are also provided with projecting shelves 898 and 899, respectively,which come together when halves 802 and 804 are closed to form a slottherebetween in which the catheter resides. Advantageously, the slotcreated by shelves 898 and 899 acts to provide reinforcement to acatheter used in adaptor 800 during the valve opening and closingprocedures, and helps to prevent buckling or kinking of the cathetertubular body when panels 883 and 884 are moved to open or close thecatheter valve.

[0146] In clinical practice, there is a direct correlation between thedistance that panel 884 moves and the distance moved by the sealerportion of a catheter valve when adaptor 800 is used. Consequently, acontrolled and known movement of panel 884 over a set direction anddistance results in a movement of the valve sealer portion in the samedirection and for substantially the same distance. Thus, with acontrolled movement adaptor such as adaptor 800, there is no need torequire a catheter having positive cooperating stops to prevent removalof the sealer portion from the catheter, as was described for thecatheter of FIGS. 1-5. The adaptor itself prevents accidental withdrawalof the sealer portion from the catheter, by precisely controlling themovement of the sealer portion within the catheter.

[0147] Accordingly, in one preferred embodiment, adaptor 800 is usedwith catheter 900, which lacks positive cooperating stops, and isdepicted in FIGS. 21 and 22. Catheter 900 has a tubular body 918 andinflatable balloon (not shown) as described above. Catheter 900 may beformed of materials and methods as described above, and may havestructural aspects identical to those described previously, except whereotherwise noted.

[0148] Catheter 900 has a proximal end 912, and a distal end (not shown)to which is mounted an inflatable balloon. A central lumen 940 extendswithin tubular body 918 between the proximal and distal ends. An opening923 to lumen 940 is present at the proximal end 912 of catheter 900. Aside-access port 922 in fluid communication with lumen 940 is providedon tubular body 918.

[0149] A sealing member 930 is inserted into lumen 940 through centrallumen opening 923. Sealing member 930 has a first region 935 which hasan outer diameter substantially the same as the outer diameter of theproximal end 912 of catheter tubular body. Region 935 has a taper 934,reducing in diameter to a second region 933 which has an outer diameterless than the inner diameter of lumen 940. Region 933 tapers over length931 to form a plug mandrel wire 932. As a consequence, region 933 andplug mandrel wire 932 are slidably insertable into the proximal opening923 of catheter 900 and may freely move within lumen 940. In onepreferred embodiment, region 935 has an outer diameter of about 0.013inches, region 933 has an outer diameter of about 0.0086 inches, andplug mandrel wire has a diameter of about 0.005 inches, with region 933and plug mandrel wire 932 being inserted into a catheter having acentral lumen 940 with an inner diameter of about 0.009 inches.

[0150] The length of sealing member region 935 extending proximally ofcatheter 900 may vary in length depending upon the intended useenvironment. For example, where catheter 900 is to be used as a guidefor other catheters in an “over-the-wire” embodiment, it is preferredthat the total length of catheter 900 and sealing member region 935 beabout 300 centimeters. Alternately, where catheter 900 is to be used ina single operator or rapid exchange embodiment, it is preferred that thetotal length of catheter 900 and region 935 be about 180 centimeters.Accordingly, with a known catheter length and use environment, anappropriate length for region 935 may be chosen.

[0151] The elements of sealing member 930 may be formed of materials andby methods as described previously. For example, regions 935 and 933 andplug mandrel wire 932 may all be made out of metals such as stainlesssteel. Alternately, combinations of materials may be used as well. Forexample, in some applications it may be desirable to manufacture regions935 and 933 out of stainless steel, while manufacturing plug mandrelwire 932 out of nitinol. Furthermore, the various sealing member regionsmay be made from a single metal wire strand coined at various points toachieve the desired dimensional tolerances, or multiple segments may bejoined together to form sealing member 930.

[0152] Where multiple segments are joined, region 935, region 933, andplug mandrel wire 932 are attached to one another by any suitable meansof bonding metal to metal, such as soldering, brazing, adhesives and thelike. In one preferred embodiment, cyanoacrylate adhesives are used toadhere these various parts of sealing member 930 to one another.

[0153] As illustrated in FIGS. 21 and 22, the outer diameter of sealingmember region 933 is less than the inner diameter of lumen 940, suchthat region 933 is slidably insertable into lumen 940. In addition, theouter diameters of the tapered portions 931 and wire 932 are also smallenough such that they too are slidably insertable in lumen 940. However,the outer diameter of region 935 is greater than the inner diameter 940,and thus only a small portion of tapered portion 934 of sealing member930 between region 935 and region 933 is insertable into lumen 940through opening 923. Advantageously, this provides for a snuginterference fit when sealing member 930 is fully inserted into catheter900. This interference fit provides a frictional force which counteractsthe tendency of the pressurized fluids and internal wire flexing in thecatheter to push sealing member 930 out of opening 923.

[0154] As illustrated in FIGS. 21 and 22, sealing member 930 hasmovement-force increasing structure which increases the force requiredto move sealing member 930 within lumen 940. The movement-forceincreasing structure consists of waves 938 a and 938 b formed in wire932 near its distal end. Waves 938 a and 938 b contact the inner surfaceof lumen 940, thereby increasing the frictional force which must beovercome to move wire 932 within lumen 940. In one preferred embodiment,where wire 932 is made of nitinol and has an outer diameter of about0.005 inches, and is inserted into a nitinol catheter which has an innerlumen 940 with a diameter of about 0.090 inches, waves are formed onwire 932 for 1½ cycles with an amplitude of about 0.016 inches toincrease the valve-opening movement force.

[0155] A lumen sealer portion 936 is coaxially and fixedly mounted onwire 932. Sealer portion 936 forms a fluid tight seal with the outerdiameter of wire 932 and the inner diameter of lumen 940, such thatfluid introduced into lumen 940 through side-access port 922 isprevented from flowing past sealer portion 936 when sealer portion 936is inserted into lumen 940 distally of side-access port 922. Sealerportion 936 forms the fluid tight seal by firmly contacting the entireinner circumference of a section of lumen 940 along a substantialportion of the length of sealer portion 936, and may be formed ofmaterials and by methods as previously described.

[0156] As shown in FIG. 21, sealer portion 936 is positioned proximallyof side-access opening 922, so that an unrestricted fluid passagewayexists between port 922 and the inflatable balloon at the distal end ofcatheter 900. This is the valve open position described above. In thisposition, region 933 is shown partially withdrawn from opening 923.Referring to FIG. 22, sealer portion 936 is positioned distally of port922, so that fluid flow between port 922 and the inflatable balloon atthe distal end of catheter 900 are substantially blocked. This is thevalve closed position described above.

[0157] Catheter 900 is changed from the valve open position to the valveclosed position by the movement of sealing member 930 and its variouscomponents. Preferably, the exact length of movement needed to changecatheter 900 from the valve closed to the valve open position is builtinto the movement function of the adaptor used to manipulate sealingmember 930 thereby opening and closing the catheter valve. In thisregard, it is preferred that catheter 900 be used with an adaptor suchas adaptor 800, which provides for such controlled precise movement.

[0158] The “stroke-length”, or overall movement in one dimension, ofsealing member 930 required to open or close the valve may be varieddepending upon the catheter requirements. When relying upon theinflation adaptor to control movement, however, it is important that themovement of the controlling elements of the adaptor be coordinated withthose of sealing member 930. With respect to adaptor 800, this isaccomplished by selecting a recess 893 dimension which precisely definesthe distance that sealing member 930 is to travel to achieve the valveopen and valve closed positions, without accidentally removing sealingmember 930 from opening 923. In one embodiment, where access port 922 ispositioned 36 mm from opening 923, a stroke length of 5.5 mm was foundto be suitable.

[0159] It will be appreciated that certain variations of the presentinvention may suggest themselves to those skilled in the art. Theforegoing detailed description is to be clearly understood as given byway of illustration, the spirit and scope of this invention beinglimited solely by the appended claims.

What is claimed is:
 1. An intravascular guidewire inflation system,comprising: a hollow metallic body having distal and proximal portions,said body having a central lumen formed therein with distal and proximalports in fluid communication with said lumen; an expandable membermounted on said distal portion of said body and adapted to be in fluidcommunication with said distal port of said central lumen, such thatfluid introduced through said proximal port will cause actuation of saidexpandable member; a valve movably inserted with respect to saidproximal port of said body, said valve movable between a first positionto seal said central lumen to prevent deactuation of said expandablemember and a second position to unseal said central lumen to allowactuation or deactuation of said expandable member; and a valve adaptorwhich may be removably mounted on said proximal portion of said body,said adaptor having an auxiliary lumen adapted to be in fluidcommunication with said proximal port of said central lumen and furtheradapted to receive a fluid delivery device for selectively actuating ordeactuating said expandable member.
 2. The guidewire inflation system ofclaim 1, wherein said metallic body comprises nitinol.
 3. The guidewireinflation system of claim 1, wherein said expandable member comprises aballoon formed from an elastomeric material selected from the groupconsisting of C-FLEX, silicones, latex and polyurethanes.
 4. Theguidewire inflation system of claim 1, wherein said metallic body has anouter diameter of from about 0.010 inches to about 0.032 inches.
 5. Theguidewire inflation system of claim 4, wherein said metallic body has anouter diameter of from about 0.014 inches to about 0.018 inches.
 6. Aguidewire inflation system, comprising: a hollow metallic body havingdistal and proximal portions, said body having a central lumen formedtherein with distal and proximal ports in fluid communication with saidcentral lumen; an inflatable member mounted on said distal portion ofsaid body in fluid communication with said distal port of said centrallumen, such that fluid introduced through said proximal port will causeinflation of said inflatable member; a valve movably inserted withrespect to said proximal port of said body, said valve movable between afirst position to seal said central lumen to prevent deflation of saidinflatable member and a second position to unseal said central lumen toallow inflation or deflation of said inflatable member; and a valveadaptor which may be removably mounted on said proximal portion of saidbody, said adaptor having an auxiliary lumen adapted to be in fluidcommunication with said proximal port of said central lumen and furtheradapted to receive a fluid delivery device for selectively inflating ordeflating said inflatable device.
 7. The guidewire inflation system ofclaim 6, wherein said metallic body comprises nitinol.
 8. The guidewireinflation system of claim 6, wherein said inflatable member comprises aballoon formed from an elastomeric material selected from the groupconsisting of C-FLEX, silicones, latex and polyurethanes.
 9. Theguidewire inflation system of claim 6, wherein said metallic body has anouter diameter of from about 0.010 inches to about 0.032 inches.
 10. Theguidewire inflation system of claim 6, wherein said metallic body has anouter diameter of from about 0.014 inches to about 0.018 inches.
 11. Theguidewire inflation system of claim 6, wherein said distal portion ofsaid hollow metallic body comprises a coil at the distal tip of saidbody.
 12. The guidewire inflation system of claim 11, wherein saidcentral lumen has a core wire inserted therein at a distal opening, andsaid core wire extends distally from said distal opening within saidcoil.
 13. The guidewire inflation system of claim 6, wherein said valvecomprises a metallic rod slidably inserted into said central lumen. 14.The guidewire inflation system of claim 13, wherein the diameter of afirst portion of said metallic rod is less than the internal diameter ofsaid central lumen and the diameter of a second portion of said metallicrod is greater than the diameter of said central lumen.
 15. Theguidewire inflation system of claim 14, wherein the diameter of saidsecond portion of said metallic rod is about 0.014 inches or less.